Ignite Creation Date:
2024-05-06 @ 6:41 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05741723
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-12
First Post:
2023-02-13
Brief Title:
OCS DCD Heart CAP Continued Follow-Up
Sponsor:
TransMedics
Organization:
TransMedics
Study Overview
Official Title:
OCS DCD Heart CAP Continued Follow-Up Post-Approval Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this post-approval study is to evaluate long-term outcomes of patients enrolled in the OCS DCD Heart and OCS DCD Heart CAP studies
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None